Stylet handling. Unauthorized changes to stimulation parameters. Activities that include sudden, excessive or repetitive bending, twisting, or stretching can cause component fracture or dislodgement. Devices with one-hour recharge per day. In addition, a component must be implanted in its approved location as listed in the following table or the entire implanted system is considered MRUnsafe. FDA's expanded . If unpleasant sensations occur, turn off stimulation immediately. Device modification. Therapeutic radiation. If unpleasant sensations occur, the device should be turned off immediately. Component handling. Patient training. However, current data shows that most patients using BurstDR Stimulation Therapy do not experience paresthesia. For more information about MR Conditional neurostimulation components and systems, including equipment settings, scanning procedures, and a complete listing of conditionally approved components, refer to the MRI procedures clinician's manual for neurostimulation systems (available online at medical.abbott/manuals). Security, antitheft, and radiofrequency identification (RFID) devices. Suicidal ideation, suicide attempts, and suicide are events that have also been reported. The clinician programmer and patient controller are not waterproof. Only apply software updates that are published directly by Abbott Medical. Please be aware that the website you have requested is intended for the residents of a particular country or countries, as noted on that site. Nonadjacent leads and extensions have the possibility of creating a conduit for stray electromagnetic energy that could cause the patient unwanted stimulation. Magnetic interference with consumer goods or electronic devices that contain magnets, such as mobile phones and smart watches, may unintentionally cause the neurostimulation system to turn on or turn off or affect communication between the device and generator; however, it will not change the prescribed programmed parameters. The use of high-output devices, such as an electrohydraulic lithotriptor, may cause damage to the electronic circuitry of an implanted IPG. Instruct patients to contact their physician if they experience any adverse effects, such as unusual pain or discomfort during stimulation and swelling, redness, tenderness, or pain around implanted components. Use extreme care when handling system components. Implantation of multiple leads. Do not bend, kink, or stretch the lead body, sheaths, or other components as this may result in damage to the component and poor function. Therapeutic magnets (e.g., magnets used in pillows, mattress pads, back belts, knee braces, wrist bands, and insoles) may unintentionally cause the neurostimulation system to turn on or off. Falling and other traumatic accidents can damage shallowly implanted components such as the leads and extensions. Do not use a clinician programmer or patient controller in an environment where explosive or flammable gas fumes or vapors are present. Poor surgical risks. Return any suspect components to Abbott Medical for evaluation. Advise patients to use their patient controller to communicate with their IPG only when needed because excessive communication with the IPG can shorten the remaining battery life. Some antitheft devices, such as those used at entrances or exits of department stores, libraries, and other public places, and airport security screening devices may affect stimulation. Component disposal. Changes secondary to neuropathic pain seen in CRPS I (RSD) may be present, but are not a diagnostic requirement for CRPS II (causalgia). Sheath insertion warning. For complete guidance, directions, and cautions on MRI safety with a specific device, please review the MRI procedure clinician's manual. Do not insert the sheath into the epidural space without the lead or guidewire inserted, as this may cause injury to the dura. For patients who do not feel paresthesia, sudden stimulation changes are less likely to occur and distract them while operating motorized vehicles, machinery, or equipment. If the lead extensions are routed in a loop, the loop will increase the potential for electromagnetic interference (EMI). If two systems are implanted, ensure that at least 20 cm (8 in) separates the implanted IPGs to minimize unintended interaction with other system components. IPG placement. Proclaim Plus Spinal Column Stimulation (SCS) System PRESCRIPTION AND SAFETY INFORMATION Read this section to gather important prescription and safety information. Application modification. Clinician training. Do not bend, kink, or use surgical instruments on the stylet, as this may damage it. If any component of the implanted neurostimulation system, such as an IPG, lead, or extension, does not meet the requirements for an MR Conditional system, do not perform an MRI scan. Instruct patients to avoid scuba diving and entering hyperbaric chambers above 1.5 atmospheres absolute (ATA) because these activities might damage the neurostimulation system. Carefully inspect the lead (in the sterile field) for damage after removing it from the sterile package. Object Category Spinal Cord Stimulation Systems: St. Jude Medical. Approved models and implant locations for an MR Conditional full system, *The IPG port plug associated with these models is also an MR Conditional component. Undesirable changes in stimulation, which may be related to cellular changes in tissue around the electrodes, changes in electrode position, loose electrical connections, or lead failure. Patient training. For more information about MR Conditional neurostimulation components and systems, including equipment settings, scanning procedures, and a complete listing of conditionally approved components, refer to the MRI procedures clinician's manual for neurostimulation systems(available online atmedical.abbott/manuals). The patient must be awake and conversant during the procedure to minimize the likelihood of nerve damage. Patients should take reasonable care to avoid devices that generate strong EMI, which may cause the neurostimulation system to unintentionally turn on or off. Some antitheft devices, such as those used at entrances or exits of department stores, libraries, and other public places, and airport security screening devices may affect stimulation. After any surgery, check the neurostimulation system for the following: Check the neurostimulator to ensure Surgery mode has been turned off, even if Surgery mode was not turned on at the beginning or during the procedure. Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned on or off. Abbott (NYSE:ABT) announced today that it received FDA approval for new magnetic resonance imaging (MRI) compatibility for the Proclaim system. Radiofrequency or microwave ablation. Proclaim XR SCS System with BurstDR stimulation offers you superior* pain relief 1. To prevent unintended stimulation, do not modify the operating system in any way. Patients should be advised to keep their mobile phones and smart watches at least 15 cm (6 in.) Emergency procedures. Patients should avoid getting too close to these types of EMI sources, which include the following examples: commercial electrical equipment (such as arc welders and induction furnaces), communication equipment (such as microwave transmitters and high-power amateur transmitters), radiofrequency identification (RFID) devices, some medical procedures (such as therapeutic radiation, static magnetic field [SMF] therapy, and electromagnetic lithotripsy), and some medical devices (such as bone growth stimulators, transcutaneous electrical nerve stimulation [TENS] devices, dental drills, and ultrasonic probes). Therefore, it is unlikely patients will need to adjust stimulation when changing positions or moving. Sheath retraction. Do not crush, puncture, or burn the IPG because explosion or fire may result. Use appropriate sterile technique when implanting leads and the IPG. Postoperatively, actively monitor patients for new or worsening symptoms of depression, suicidal thoughts or behaviors, or changes in mood or impulse control. Safety and effectiveness of neurostimulation for use during pregnancy and nursing have not been established. Abbott is providing these links to you only as a convenience, and the inclusion of any link does not imply endorsement of the linked site by Abbott. If such exposure occurs, clean the affected parts with sterile, deionized water or sterile water for irrigation, and dry them completely prior to lead connection and implantation. If two systems are implanted, ensure that at least 20 cm (8 in.) If they must go through a gate or doorway containing this type of device, patients should turn off their IPG and proceed with caution, being sure to move through the device quickly. Set the electrosurgery device to the lowest possible energy setting. Implanting physicians or anesthesiologists should consult practice guidelines for the intraoperative management of patients with diabetes. (Bluetooth is a registered trademark of Bluetooth SIG, Inc.). away from the generator and avoid placing any smart device in a pocket near the generator. Do not use a clinician programmer or patient controller around explosive or flammable gas fumes or vapors. Some models of this system are Magnetic Resonance (MR) Conditional, and patients with these devices may be scanned safely with magnetic resonance imaging (MRI) when the conditions for safe scanning are met. Mobile phones. Confirm that the neurostimulation system is functioning correctly during the implant procedure and before closing the neurostimulator pocket. The following procedures are contraindicated for patients that have been implanted with this device: Diathermy therapy. Pregnancy and nursing. 71376 MAT-2006974 v2.0 | Item approved for U.S. use only. High-output ultrasonics and lithotripsy. Diathermy therapy. maximize the distance between the implanted systems; Use in patients with diabetes. Proclaim XR SCS System Meaningful relief from chronic pain. Sources of therapeutic radiation include therapeutic X rays, cobalt machines, and linear accelerators. Do not implant a device if the sterile package or components show signs of damage, if the sterile seal is ruptured, or if contamination is suspected for any reason. If the patient requires a CT scan, all stimulation should be turned off before the procedure. Return any suspect components to Abbott Medical for evaluation. The use of high-output devices, such as an electrohydraulic lithotripter, may cause damage to the electronic circuitry of an implanted IPG. Patients should be instructed to avoid bending, twisting, stretching, and lifting objects over 2 kg (5 lb) for six to eight weeks after implantation of a neurostimulation system. In the clinical experience with this device, patients have experienced few effects when moving from lying down to sitting up. Stimulation in unwanted places (such as radicular stimulation of the chest wall), Lead migration, causing changes in stimulation or reduced pain relief, Epidural hemorrhage, hematoma, infection, spinal cord compression, or paralysis from placement of a lead in the epidural space, Paralysis, weakness, clumsiness, numbness, or pain below the level of the implant, Persistent pain at the electrode or generator site, Seroma (mass or swelling) at the generator site, Allergic or rejection response to implant materials, Implant migration or skin erosion around the implant. This neurostimulation system is contraindicated for patients who are. This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures. INTENDED USE This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures. Store components and their packaging where they will not come in contact with liquids of any kind. Component manipulation by patients. IPGs contain batteries as well as other potentially hazardous materials. Securing the lead with the lead stabilizer will mitigate this risk. Device modification. A summary of the safety and clinical performance (SSCP) for these devices will be published at https://ec.europa.eu/tools/eudamed by the Notified Bodies in accordance with the requirements of EU MDR 2017/745 and associated timelines. Use extreme care to not damage the lead with the sharp point of the tunneling tool. Therefore, the literature and clinical studies represent the safety and effectiveness of this neurostimulation system. Securing the anchor. This system is contraindicated for patients who meet the following criteria: The following procedures are contraindicated for patients with a deep brain stimulation system. Using the tunneling tool. Deep brain stimulation potentially has the following adverse effects: Possible surgical complications. ), Undesirable changes in stimulation, which may be related to cellular changes in tissue around the electrodes, changes in electrode position, loose electrical connections, or lead failure or breakage, Stimulation in unwanted places (such as stimulation of the chest wall), Epidural hemorrhage, hematoma, infection, spinal cord compression, or paralysis from placement of a lead in the epidural space Cerebrospinal fluid (CSF) leakage, Paralysis, weakness, clumsiness, numbness, sensory loss, or pain below the level of the implant, Pain or bleeding where the needle was inserted, Seroma (mass or swelling) at the implant site, Allergic or rejection response to device or implant materials, Hardware malfunction that requires replacing the neurostimulator, Pain from a noninjurious stimulus to the skin or an exaggerated sense of pain, Formation of reactive tissue in the epidural space around the lead, which can cause delayed spinal cord compression and paralysis and requires surgical intervention (Time to onset can range 23 from weeks to many years after implant.). Wireless use restrictions. The system is intended to be used with leads and associated extensions that are compatible with the system. Follow proper infection control procedures. 737202011056 v5.0 | Item approved for U.S. use only. Do not implant a device if the sterile package, the device, or any device components show signs of damage, tampering, or if the sterile seal is ruptured, or contamination is suspected for any reason. This neurostimulation system is similar in technology and intended use to the systems reported in the literature and clinical studies. When inserting the lead-sheath assembly through the needle into the epidural space, tighten the lead stabilizer to prevent lead migration out of the sheath. Nerve damage may result from traumatic or surgical nerve injury. The needle will be inserted at a steeper angle than in an antegrade approach and there is a greater chance of dural puncture that will lead to a cerebrospinal fluid leak. These electrically insulated wires transmit electrical impulses to the nerves targeted by the neuromodulation device. Package or component damage. If the sheath needs to be retracted from the epidural space, verify that the steering wing is rotated away from the needle mark no more than 90 degrees. Bending the sheath. WARNING:For a neurostimulation system to be MR Conditional, all implanted components must be approved MR Conditional models and implanted in approved locations according to the following table. Do not suture directly onto the lead to avoid damaging the lead. Security, antitheft, and radiofrequency identification (RFID) devices. Return all explanted components to Abbott Medical for safe disposal. The effect of other implanted devices, including deep brain stimulators, peripheral nerve stimulators, implanted drug delivery pumps, and cochlear implants on the neurostimulation system are unknown. In addition to those risks commonly associated with surgery, the following risks are associated with implanting or using this neurostimulation system: Unpleasant sensations or motor disturbances, including involuntary movement, caused by stimulation at high outputs; if either occurs, turn off your IPG immediately, Undesirable changes in stimulation, which may be related to cellular changes in tissue around the electrodes, changes in electrode position, loose electrical connections, or lead failure, Persistent pain at the electrode or IPG site, Seroma (mass or swelling) at the IPG site. Unilateral or bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN) for the management of intractable, chronic dystonia, including primary and secondary dystonia, for patients who are at least 7 years old. Do not bring the suture needle in contact with an IPG, lead, or extension, or the component may be damaged. Nonadjacent leads can possibly create a conduit for stray electromagnetic energy that could cause the patient unwanted stimulation. Low frequencies. During the implant procedure, if an electrosurgery device must be used, take the following actions:. Additionally, RFID devices, which are often used to read identification badges, as well as some tag deactivation devices, such as those used at payment counters at stores and loan desks at libraries, may also affect stimulation. Store components and their packaging where they will not come in contact with liquids of any kind. To prevent unintended stimulation, do not modify the operating system in any way. Do not use the application if the operating system is compromised (i.e., jailbroken). Return them to Abbott Medical for proper disposal. Some models of this system are Magnetic Resonance (MR) Conditional, and patients with these devices may be scanned safely with magnetic resonance imaging (MRI) when the conditions for safe scanning are met. Before your patient undergoes an MRI scan: Confirm the MR Conditional components and location of the system. System testing. Inaccurate ECG results may lead to inappropriate treatment of the patient. If you are unsure of the policy that applies to the use of this device, please ask for authorization to use it before turning it on. The neurostimulation system may interfere with the normal operation of another active implanted device, such as a pacemaker, defibrillator, or another type of neurostimulator. Some models of this system are Magnetic Resonance (MR) Conditional, and patients with these devices may be scanned safely with magnetic resonance imaging (MRI) when the conditions for safe scanning are met. Do not resterilize or reimplant an explanted system for any reason. If needed, return the equipment to Abbott Medical for service. Damage to the system may not be immediately detectable. Patients should cautiously approach such devices and should request help to bypass them. If needed, return the equipment to Abbott Medical for service. Safety and effectiveness of neurostimulation for use during pregnancy and nursing have not been established. Implantation at vertebral levels above T10. Generators contain batteries as well as other potentially hazardous materials. 74373 MAT-2300644 v2.0 | Item approved for U.S. use only. The safety and efficacy of implantation of leads implanted above the T10 vertebral level have not been evaluated. For specific indications, contraindications, instructions, warnings, precautions, and adverse effects about system components available in your country or region, see the approved clinician's manual for those components. ABBOTT PARK, Ill., Jan. 26, 2023 /PRNewswire/ -- Abbott (NYSE: ABT) announced today that the U.S. Food and Drug Administration (FDA) has approved its Proclaim XR spinal cord stimulation (SCS) system to treat painful diabetic peripheral neuropathy (DPN), a debilitating complication of diabetes. Patients with implanted Abbott leads should avoid scuba diving in more than 30 m (100 ft) of water or entering hyperbaric chambers above 4.0 atmospheres absolute (ATA) for any length of time, as this may damage the neurostimulation system. Sterile components in this kit have been sterilized using ethylene oxide (EtO) gas before shipment and are supplied in sterile packaging to permit direct introduction into the sterile field. Abandoned leads and replacement leads. We know that MRI scans are an important and trusted visualization tooland thats why weve designed our devices and technologies to fit as seamlessly as possible into this critical step in your diagnostic workflow. Use caution when securing the soft tissue anchor because damage to the anchor or lead can occur and result in failure of the system. However, some patients may experience a decrease or increase in the perceived level of stimulation. Safety has not been established for TMS or ECT in patients who have an implanted neurostimulation system. IPGs contain batteries as well as other potentially hazardous materials. Do not use excessive pressure when injecting through the sheath. Do not place the IPG deeper than 4.0 cm (1.57 in) because the clinician programmer or patient controller may not communicate effectively with the IPG. High stimulation outputs and charge density limits. The IPG should be placed into the pocket, at a depth not to exceed 4 cm (1.57 in), with the logo side facing toward the skin surface. Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned on or off. Magnetic resonance imaging (MRI). Remove leads slowly. Do not use short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy (all now referred to as diathermy) on patients implanted with a neurostimulation system. Read this section to gather important prescription and safety information. Avoid programming either device in a unipolar mode (using the devices can as an anode) or using neurostimulation system settings that interfere with the function of the implantable cardiac system. Advise patients to not use their device when engaging in activities that might cause it to get wet, such as swimming or bathing. Sources of therapeutic radiation include therapeutic X rays, cobalt machines, and linear accelerators. These activities may cause lead movement, resulting in under stimulation or overstimulation for the patient. These activities include but are not limited to climbing ladders and operating potentially dangerous machinery, power tools, and vehicles. ** Generator disposal. Placing the IPG. The following warnings apply to this neurostimulation system. Conditional 5. Advise patients who experience these types of stimulation changes to turn down the amplitude or turn off the IPG before making extreme posture changes or abrupt movements such as stretching, lifting their arms over their heads, or exercising. This neurostimulation system is indicated for spinal column stimulation via epidural and intraspinal lead access to the dorsal root ganglion as an aid in the management of moderate to severe chronic intractable* pain of the lower limbs in adult patients with complex regional pain syndrome (CRPS) types I and II. The Eterna SCS System is contraindicated for patients who are unable to operate the system or who have failed to receive effective pain relief during trial stimulation. If interference occurs, try holding the phone to the other ear or turning off the phone. Scuba diving or hyperbaric chambers. Case damage. A recharge-by date is printed on the packaging. Therapeutic radiation may damage the electronic circuitry of an implanted neurostimulation system, although no testing has been done and no definite information on radiation effects is available. Do not use the application if the operating system is compromised (that is, jailbroken). Have the patient check the device for proper functioning, even if the device was turned off. Battery precaution. Lead inspection. Guidance and conditions for MRI safety with neuromodulation systems, neuromodulation.abbott/us/en/healthcare-professionals/mri-support.html, Upper buttock, low back, midline, flank or abdomen, Upper buttock, low back, flank, or abdomen, 6170 directional lead, 30 cm, 0.5-mm spacing, black, Fully implanted in the brain, routed under the scalp, 6010 Guardian cranial burr hole cover system, Fully implanted in the brain, routed under the scalp and connected to an extension, Head and neck, routed to the IPG on the same side of the body as the IPG, Lead-only systems, which consist of at least one implanted lead connected to a lead protection boot, as well as an optional cranial burr hole cover, Full systems, which consist of at least one implantable pulse generator (IPG), lead and extension, as well as an optional cranial burr hole cover.